- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06286774
Sleep as a Mechanism of Change in Alcohol Use (ReTRAIN)
February 23, 2024 updated by: Mary E Miller, University of Missouri-Columbia
Sleep as a Mechanism of Change in Alcohol Use Outcomes Among Heavy-Drinking Adults
This project aims to evaluate improvement of insomnia as a mechanism of improvement in alcohol use outcomes.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Heavy alcohol use is prevalent in the United States and results in significant physical and psychological burden.
One in 10 adults in the United States reports binge drinking on a weekly basis, and few are willing to seek mental health treatment.
Thus, additional strategies are needed to engage and treat individuals at risk for alcohol-related harm.
Half of those who screen positive for hazardous drinking report clinically significant symptoms of insomnia.
Insomnia tends to be less stigmatized than other mental health disorders, and it is one condition for which the field has highly efficacious treatment.
Thus, one potential strategy to engage individuals in mental health treatment and reduce the burden of alcohol use in the United States is to target insomnia.
This project aims (1) to examine change in insomnia as a mediator of insomnia treatment effects on alcohol use outcomes and sex as a moderator of those effects and (2) to identify mechanisms linking change in insomnia to alcohol use outcomes.
Adults who drink alcohol and have insomnia will be randomly assigned to Cognitive Behavioral Therapy for Insomnia (CBT-I, n=112) or waitlist control (WLC, n=112).
Outcomes will be assessed weekly during treatment, at the end of the active intervention period (post-treatment), and at 1-, 3-, and 6-month follow-ups.
Primary outcomes include insomnia severity, drinking quantity, and alcohol-related consequences.
Data will be analyzed using multilevel models.
The results of the proposed research will inform research and clinical practice by determining the extent to which sleep operates as a mechanism of alcohol behavior change.
Study Type
Interventional
Enrollment (Estimated)
256
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mary Beth Miller Miller, PhD
- Phone Number: 573-882-1813
- Email: millmary@health.missouri.edu
Study Contact Backup
- Name: Rebecca Patterson, BSc
- Phone Number: 573-882-8598
- Email: rap5z6@umsystem.edu
Study Locations
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri-Columbia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- report heavy drinking in a typical week in the past month
- meet DSM-5 criteria for Alcohol Use Disorder
- meet DSM-5 and research diagnostic criteria for Insomnia Disorder
Exclusion Criteria:
- ≥50 years
- unable to provide informed consent
- report contraindications for CBT-I (mania or seizure disorder)
- moderate to severe sleep apnea that is untreated
- have symptoms requiring immediate clinical attention (e.g., psychosis, suicide plan)
- are already receiving behavioral treatment for insomnia or alcohol use
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT-I
Individual Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered once a week for five (5) weeks.
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Cognitive Behavioral Therapy for Insomnia (CBT-I).
Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks.
Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
Other Names:
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No Intervention: Waitlist control
Control participants will receive CBT-I at the end of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Symptoms
Time Frame: Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using Insomnia Severity Index (ISI).
Response options range from 0 (not at all worried) to 4 (very much worried), with total scores ranging from 0 to 28 and higher scores indicating more severe insomnia.
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Change from baseline to mid-treatment (week 4) to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Drinking quantity
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using Timeline Followback and Daily Drinking Questionnaire.
Typical weekly drinking quantity estimates will be summed to create a "drinks per week" total score, which will be used as our outcome variable.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Alcohol-related consequences
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using the Drinker Inventory of Consequences (DrINC).
Scores range from 0 to 120, with higher scores indicating more consequences.
The common consequence subscale scores range from 0 to 18.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment willingness (alcohol)
Time Frame: Change from baseline to post-treatment (week 6)
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Assessed using a modified Treatment Willingness Scale.
Participants rate their agreement with the statement that they would seek treatment for 5 medical and 5 mental health conditions if they experienced problems related to them.
Willingness to seek alcohol or drug treatment is assessed on a 0-5 scale, with higher scores indicating greater willingness.
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Change from baseline to post-treatment (week 6)
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Alcohol craving
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using the Penn Alcohol Craving Scale (PACS).
PACS evaluates thoughts about drinking by assessing the duration, frequency, and intensity of such thoughts.
Scores range 0-30, with higher scores indicating more severe craving.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Negative emotionality
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Negative emotionality will be assessed as a latent construct of mood, anxiety, depression, PTSD symptoms, and difficulties with emotion regulation.
Changes in individual symptoms will be reported for descriptive purposes.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Response inhibition
Time Frame: Change from baseline to post (week 6) to 3-month follow-up
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Assessed using the Stroop Task.
Average reaction time (RT; measured from color word/color rectangle stimuli onset until a response is made) on correct trials for each trial type (control trials, congruent trials, incongruent trials) were computed as the outcomes of interest.
Higher RTs indicate worse performance.
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Change from baseline to post (week 6) to 3-month follow-up
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Working memory
Time Frame: Change from baseline to post (week 6) to 3-month follow-up
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Assessed using the N-Back Task.
The dependent measure is the proportion of correct responses (yes and no) across all four blocks.
Omissions are counted as errors.
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Change from baseline to post (week 6) to 3-month follow-up
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Delay discounting
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using the Monetary Choice Questionnaire (MCQ).
Participants indicate if they would rather receive a smaller amount of money now or a greater amount of money in a specified amount of time (e.g., 100 days, 2 days).
The MCQ is scored using a logarithmic subject-specific discount rate (k variable).
Higher k values indicate a greater preference for smaller, immediate rewards over larger, delayed reward.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Alcohol to help with sleep
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using daily sleep diaries.
The outcome will be percentage of days using alcohol to help with sleep.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Heartrate variability
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using Fitbit Charge 6. Heart-rate variability (HRV) is an indicator of activity in the autonomic nervous system that quantifies changes in intervals between heart beats.
In general, HRV increases with increasing parasympathetic activity, then plateaus and decreases with increasing sympathetic activity.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Dysfunctional Beliefs and Attitudes about Sleep Scale
Time Frame: Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Assessed using the revised Dysfunctional Beliefs and Attitudes about Sleep Scale.
Responses range from 0 to 70, with higher scores indicating more dysfunctional beliefs.
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Change from baseline to post-treatment (week 6) to 1-, 3-, and 6-month follow-ups
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Study Registration Dates
First Submitted
February 2, 2024
First Submitted That Met QC Criteria
February 23, 2024
First Posted (Estimated)
February 29, 2024
Study Record Updates
Last Update Posted (Estimated)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2096884
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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